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RECRUITING
NCT07154147
PHASE4

Oral vs IV Sedation for Cataract Surgery in Older Adults

Sponsor: University of California, San Francisco

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to find out if taking a pill (oral sedation) works just as well as getting medicine through a vein (IV sedation) to help older adults feel relaxed during cataract surgery. We are also studying how these two methods affect recovery, especially thinking and memory after surgery, and how satisfied people are with their care. Participants in this study will be randomly assigned to receive either oral sedation (+ IV placebo) or IV sedation (+ oral placebo) before their cataract surgery. They will complete short surveys about their thinking and recovery before and after surgery, and will be contacted by phone after surgery to check on their recovery. The results of this study will help doctors understand if a simple pill can be a safe and effective alternative to IV sedation for cataract surgery.

Official title: Cataract Oral vs IV Sedation Pilot RCT: A Non-inferiority Assessment of Perioperative Safety and Cognitive Recovery in Older Adults

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-08-12

Completion Date

2025-11

Last Updated

2025-09-04

Healthy Volunteers

No

Interventions

DRUG

Alprazolam

Participants will take oral alprazolam 0.5 mg 15 to 90 minutes before surgery to promote relaxation and reduce anxiety. An IV placebo (normal saline) will be administered to maintain blinding.

DRUG

Midazolam

Participants will receive IV midazolam 1 mg immediately before surgery to promote relaxation and reduce anxiety. An oral placebo pill will be used to maintain blinding.

Locations (1)

UCSF Wayne and Gladys Valley Center for Vision, Mission Bay

San Francisco, California, United States